Table 3.
Key supply-side policies for biosimilars.
| Policy | Belgium | France | Germany | Greece | Hungary | Italy | Polanda | Spain | Sweden | UK |
|---|---|---|---|---|---|---|---|---|---|---|
| IRP | × | ✓ | ✓ | × | ✓ | × | ✓ | ✓ | × | × |
| ERP | × | × | × | ✓ | × | ✓ | ✓ | × | × | × |
| HTA | ✓ | ✓ | × | × | × | ✓ | ✓b | × | ✓ | ✓ |
| Price linkage | ✓ | ✓ | ✓ | × | ✓c | ✓c | ✓c | ✓ | ✓ | ✓ |
| Price re-evaluation | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Tendering | ✓ | ✓ | ✓ | × | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
IRP: internal reference pricing; ERP: external reference pricing; HTA: health technology assessment; ×: absence of policy; ✓: presence of policy.
Polish regulations do not differentiate between small molecule generics and biosimilars.
Only when there is no equivalent medicine on the market.
Mandatory price reduction (defined price cut).